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Erectile DysfunctionPhase 1NCT05585931

Effect of TPN171H on Spermatogenesis

A Phase 1 study testing TPN171H 10mg in people with Erectile Dysfunction, run by Vigonvita Life Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a phaseⅠstudy to determine the acute effects of TPN171H on semen function in healthy male subjects. Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Erectile Dysfunction
What is being tested?
TPN171H 10mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteChina
Study dates
15 Nov 2022to 16 Dec 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male aged 18~40years (included)
  • Body Mass Index of 19 to 28 kg/m2; Body weight no less than 50 kg;
  • Sperm concentration ≥15*10^6/ml, Sperm motility(a+b(%))≥32%, Semen volume ≥1.5 ml, Liquefaction time≤60 min
  • Sperm sample should be collected after a minimum of 2 days and a maximum of 7 days of sexual abstinence.
  • Take reliable contraceptive measures
  • Physical examination, vital signs examination, laboratory examination, ECG were normal or abnormal without clinical significance;
  • Be able to understand and willing to sign the Informed Consent Form;

Who cannot join

  • People with azoospermia, teratozoospermia, moderate-to-severe asthenozoospermia, and moderate-to-severe oligozoospermia and other abnormal semen disease
  • People with vasectomy and ligation
  • People who have a history of hypersensitivity to other PDE5 inhibitors or TPN171H;
  • There are clear diseases of the central nervous system, cardiovascular system, digestive system (including those with severe fatty liver in B-ultrasound examination), respiratory system, urinary system, blood system, metabolic disorders, etc. and require medical intervention or other unsuitable clinical trials Those with tested diseases (such as history of mental illness, etc.); those with a history of orthostatic hypotension;
  • Blurred vision or a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinal degeneration (such as retinitis pigmentosa), macular degeneration;
  • A history of fainting needles or fainting blood;
Show all 14Show fewer
  • Blood loss or blood donation of 400 mL or more within 3 months before administration;
  • Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 2 weeks before administration
  • those who have participated in other drug clinical trials and received trial drugs within 3 months before
  • Positive results of alcohol breath test, or current/previous alcoholics (drinking more than 21 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL wine);
  • Urine drug screening positive；
  • Smoking more than 10 cigarettes per day ；
  • Those who are positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;
  • he investigator believes that there are other factors that are not suitable for participating in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100032

Other trials in China

About this study

Official title: Evaluate the Acute Effects of a Single Oral Dose of TPN171H on Semen Function in Healthy Male Subjects in China

This study is a phaseⅠstudy to determine the acute effects of TPN171H on semen function in healthy male subjects.

Read the detailed description

Safety Study in male subjects

Being tested
TPN171H 10mg, TPN171H Placebo
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TPN171H 10mgDrug

    Subjects were given 10mg TPN171H tablet with 240 mL warm water under fasting condition.

  • TPN171H PlaceboDrug

    Subjects were given Placebo with 240 mL warm water under fasting condition.

Study groups in NCT05585931
Study groupRoleWhat they receive
Cohort 1Experimental9 subjects receive 10 mg TPN171H for Period 1; Placebo for Period 2
Receives: Drug: TPN171H 10mg; Drug: TPN171H Placebo
Cohort 2Experimental9 subjects receive Placebo for Period 1; 10 mg TPN171H for Period 2
Receives: Drug: TPN171H 10mg; Drug: TPN171H Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect on semen function

    The parameters of semen routine analysis were compared between TPN171H tablets and placebo.

    Measured: 1.5 hours after taking the medicine

  2. Seminal plasma exposure

    TPN171H exposure in seminal fluid

    Measured: 1.5 hours after taking the medicine

Secondary outcomes (1)

  1. Adverse events

    adverse events (each study visit); laboratory evaluations; electrocardiogram and physical examination; vital signs will be assessed at various times during the study

    Measured: From administration of study drug through 3 days after last administration of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2022
  2. Study start15 Nov 2022
  3. Primary completion16 Dec 2022
  4. Study completion16 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05585931
Sponsor's protocol ID
TPN171H-12
Status last verified
Feb 2023
First submitted
18 Sep 2022
Last updated
21 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yang Y, Zhang Z, Li L, Jiang Z, Juan J, Duan H, Wang Z, Jiang H. Evaluation of the acute effects of single-dose TPN171 on semen quality in healthy Chinese male volunteers. Br J Clin Pharmacol. 2025 Aug;91(8):2401-2408. doi: 10.1002/bcp.70049. Epub 2025 Apr 3.

    PubMed 40181588

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TPN171H 10mg in people with Erectile Dysfunction, run by Vigonvita Life Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect on semen function (time frame: 1.5 hours after taking the medicine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05585931, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.

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